Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial — EPL  

Gastric Cancer Clinical Trial

Official title: Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial (EPL Study)

Status Recruiting

Clinical Trial Summary

This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy

Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence

Clinical Trial Description

Gastric cancer is the second most common cause of cancer death worldwide. Surgery is the mainstay treatment for cure. Peritoneum is a common site of recurrence and the prognosis in patients with peritoneal recurrence is dismal. Hence, prevention is essential to patient's outcomes. In patients with serosal invasion, about half experience peritoneal recurrence within first 2 years after surgery, even after curative surgery. Peritoneal metastasis is caused by the implantation of free cancer cells in the peritoneal cavity exfoliated from the primary tumor before or during curative surgery. It is well known that cancer cells spillage could occur during surgery due to manipulation or even after lymph node dissection. If we can remove these free exfoliated cancer cells on the peritoneal lining, we may reduce the risk of tumor recurrence.

Recently, a study has demonstrated a dramatic reduction of peritoneal recurrence with extensive peritoneal lavage (EPL) in patients who underwent curative resection of gastric cancer. EPL was performed after the curative operation . The peritoneal cavity was washed with normal saline which is then followed by the complete aspiration of the fluid. This procedure was done 10 times using 1 liter of normal saline. The method was based on the 'limiting dilution theory' in which the method can dilute the number of free cancer cells to minimal hence reduce the risk of tumor implantation. In this study, among patients with microscopic peritoneal metastasis, peritoneal recurrence developed in 40% of patients with EPL and surgery, compared to 89.7% in patients with surgery alone. EPL carries minimal risk to patients. It is simple and inexpensive, and it is not time consuming. Hence, it may be an effective strategy for treatment of gastric cancer. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT02140034
• Study type: Interventional
• Source: National University Hospital, Singapore
• Contact: Jimmy So, MBChB
• Phone: +65 6772 5555
• Email: sursbyj@nus.edu.sg
• Status: Recruiting
• Phase: N/A
• Start date: May 2013
• Completion date: May 2016